GlaxoSmithKline Presents Avandia Data To FDA

Armen Hareyan's picture
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GlaxoSmithKline's Avandia demonstrates the weight of scientific evidence available to address a question of increased risk of cardiovascular ischemic events.

This question was raised by different meta-analyses performed by GSK, the FDA and one published in the NEJM. Although a meta-analysis can help raise scientific questions for further investigation, such analyses can also have significant limitations. GSK believes a full and scientific evaluation of all the data does not confirm the safety questions originally raised.

Long-term clinical trials -- particularly those designed to test a specific outcome in patients with the disease -- are the most robust tools available to answer questions raised by meta-analyses. A 1997 published review of meta-analyses revealed 33% of the conclusions of meta-analyses are not confirmed by subsequent clinical trials.

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Avandia is the most widely studied oral anti-diabetic medicine for the treatment of type 2 diabetes. The extensive data for Avandia includes:

-- 116 clinical trials in over 52,000 patients. These include:

-- Three, long-term clinical trials in more than 14,000 patients: ADOPT, DREAM, RECORD, with RECORD specifically studying cardiovascular effects

-- A study in a high cardiovascular-risk population:

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